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BSI BS EN ISO 13408-2:2018

Aseptic processing of health care products -- Sterilizing filtration
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BSI BS EN ISO 13408-2:2018

Aseptic processing of health care products -- Sterilizing filtration

PUBLISH DATE 2018
PAGES 44
BSI BS EN ISO 13408-2:2018

This document specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.

This document is not applicable to removal of viruses.

Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).

This document is not applicable to high efficiency particulate air (HEPA) filters.

This document does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

SDO BSI: British Standards Institution
Document Number ISO 13408-2
Publication Date April 10, 2018
Language en - English
Page Count 44
Revision Level
Supercedes
Committee CH/198
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